Pharmaceutically acceptable particulate sparingly crosslinked non-digestible quaternary ammonium substituted polystyrene anion exchange resins, such as cholestyramine resin powder, are known hypocholesterolaemic agents. See, for example U.S. Pat. No. 3,383,281 to Wolf et al. incorporated by reference herein.
Such resins are administered orally, generally in the form of a powder which is admixed with a beverage, such as water, milk, fruit juice or other non-carbonated beverage, or with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple. In the intestinal tract, the indigestible resin adsorbs and combines with bile acids to form an insoluble complex which is excreted. The increased loss of bile acids due to resin administration leads to an increased oxidation of cholesterol to bile acids, a decrease in beta lipoprotein or low density lipoprotein plasma levels and a decrease in serum cholesterol levels. Although in man, the oral administration of such resins results in an increase in hepatic synthesis of cholesterol, plasma cholesterol levels fall.
Accordingly, such resins are useful in the reduction of elevated serum cholesterol in patients with hypercholesterolemia and in the relief of pruritis.
Unfortunately such resins in particulate form characteristically exhibit a chalky, gritty texture or taste in the mouth of the patient, even when combined with a beverage, soup or pulpy fruit. In some patients, this undesirable characteristic of the resin may elicit a gagging reflex. As a result, patient compliance to the self administration of the resin orally may be reduced.
It is therefore an object of the present invention to provide a pharmaceutically acceptable gelled composition containing an effective hypocholesterolaemic amount of a particulate sparingly crosslinked non-digestible quaternary ammonium substituted polystyrene anion exchange resin which possesses a high degree of palatability.
It is a further object of the present invention to provide a method treating a patient by orally administering an effective hypocholesterolaemic amount of such gelled composition.
These and other objects of the invention are apparent from the following specification disclosures.